Safety and pharmacokinetics of LV232 capsules in healthy volunteers

Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules in Chinese Healthy Volunteers

This study is testing the safety and how the body processes LV232 capsules in healthy volunteers to see how different doses and food affect it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Vigonvita Life Sciences (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06279533 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetic profiles of LV232 capsules through a two-part approach involving multiple ascending doses and a food effect assessment. A total of 48 healthy subjects will be enrolled, with the first part focusing on administering varying doses of LV232 in a randomized, double-blinded, placebo-controlled design. The second part will assess how food intake affects the pharmacokinetics of LV232 using a crossover design. Participants will receive either the investigational product or placebo over a series of days, with careful monitoring for safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 45 with a specific body weight and BMI range.

Not a fit: Patients with known hypersensitivity to LV232 or those with significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and optimal dosing of LV232, potentially leading to its use in future therapeutic applications.

How similar studies have performed: Previous studies on similar pharmacokinetic assessments have shown promising results, indicating that this approach is well-established.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 to 45 years old, males or females;
2. Body weight no less than 50.0 kg for male, no less than 45.0 kg for female,Body Mass Index of 19.0 to 26.0kg/m2;
3. Physical examination, vital signs examination, laboratory examination, electrocardiogram examination and B-ultrasound examination results were normal or abnormal without clinical significant;
4. Subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed;
5. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.

Exclusion Criteria:

1. Subjects with hypersensitivity to LV232 or any of the excipients;
2. Subjects with allergic diseases or allergic constitution;
3. Subjects with skin diseases or a history of skin allergies;
4. Subjects with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, Hematologic System, metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
5. Blood donation or blood loss ≥ 400 mL within 3 months , or have a history of blood product use history
6. Subjects who have participated in clinical trials of other drugs within 3 months before screening;
7. Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products orally within 2 weeks before screening;
8. Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content);
9. Subjects who smoked more than 10 cigarettes or equivalent amounts of tobacco a day within one year before screening;
10. Subjects who can't quit smoking and drinking during the experiment;
11. Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);
12. Abnormal and clinically significant chest radiographs (anteroposterior);
13. B ultrasound examination showed moderate to severe fatty liver;
14. Pregnant or lactating woman or male subjects whose spouse has a child care plan within 3 months;
15. The investigator believes that there are other factors that are not suitable for participating in this trial.

Where this trial is running

Shanghai

• Shanghai Xuhui Central Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Chen Yu — Shanghai Xuhui Central Hospital
• Study coordinator: Huaqing Duan

Conditions Healthy Subjects; LV232; Phase I; dose-escalation; Tolerability; Pharmacokinetic; food effect